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FDA Has Double Standard On Testosterone

Posting Date: 01/03/2005

SEX! From the beginning of human history sex has been a topic of compelling interest. And people can?t seem to get enough. They have been trying to concoct aphrodisiacs for thousands of years.

Truffles, oysters, artichokes and crocodile kidneys all seemed exotic enough to stimulate sexual desire. Rhinoceros horn and ginseng have been popular in east Asia for centuries. But despite a lot of wishful thinking, there is no evidence that such products actually work as love potions.

Although Viagra, Levitra and Cialis allow many men to achieve a satisfactory erection, they are not aphrodisiacs. But the idea of better performance is enough to increase some men?s interest in sexual activity.

What about their partners, though? The popularity of drugs for ED has revealed a surprising number of women who just aren?t very interested in sex. Many of them have lost their libido, in part because of postmenopausal hormonal changes.

An FDA panel just recommended against approving the only medication that has been shown to increase women?s sex drive. The medicine is testosterone.

Testosterone is normally thought of as a male sex hormone, but women make it too. With age, levels can drop in both men and women.

Research dating to 2000 showed that a testosterone patch or sublingual (under the tongue) tablet could increase sexual fantasies and arousal in women significantly more than placebo.

Why did the expert committee balk at a testosterone patch (Intrinsa) for women? For one thing, increased desire is harder to measure than improved erections. The panel was not convinced that the patch was so much better than placebo that it deserved approval.

The experts also suggested that there are concerns about long term safety. Fears were expressed that testosterone might carry cardiovascular risks or even increase the danger of breast cancer. Memories of the HRT scandal may have influenced the panel.